Abuse of prescription drugs (particularly opioids) has become a serious societal problem. Such abuse places an enormous economic burden on society due to increased health care, work place, and criminal justice costs. Several routes of administration are commonly attempted by abusers. For example, the oral solid dosage form may be crushed or pulverized into a powder and administered by an intranasal route (i.e., snorted), or dissolved in a suitable solvent (e.g., water) and administered by a parenteral route (i.e., injected intravenously), swallowed after chewing in the mouth, or swallowed after physical manipulation.
Attempts have been made to diminish the abuse of opioid solid dosage forms. One approach has been to include in the dosage form an opioid antagonist that is not orally active but will substantially block the analgesic effects of the opioid if one attempts to dissolve the opioid and administer it parenterally. Another approach has been to include gel-forming high molecular weight polymers that confer plasticity to the dosage form rendering them difficult to crush and pulverize into powder. A commercially available extended release, abuse deterrent tablet of oxycodone HCl utilizes a physical barrier to deter both physical manipulations (e.g., reduction of the particle size using common household tools and chemical extraction of oxycodone HCl in an injectable solvent). However, these abuse deterrent tablets are still being abused by swallowing after chewing, swallowing after physical manipulation, and IV injection after the extraction of oxycodone HCl in a small volume of water (<10 mL) from both intact and cut tablets.
Thus, there is a need for oral dosage forms that provide extended release of the active ingredient yet are resistant to abuse by oral, intranasal, and IV injection via chewing, grinding, and chemical extraction.